Analyses of MRI and VEP data confirm anatomical and physiological improvements, indicating remyelination and neuronal repair in the brains of MS patients treated with CNM-Au8 during the long-term extension of VISIONARY-MSOver 90% of participants who showed improvements in cognition and vision also demonstrated corresponding improvements on MRI and visual electrophysiology tests SALT LAKE CITY, April 08, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (NASDAQ:CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinic ...

About Clene Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells' survival and function via a mec ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 CLENE INC. (Exact name of registrant as specified in its charter) Delaware 85-2828339 (State or other jur ...

Clene Inc. (CLNN) came out with a quarterly loss of $1.67 per share versus the Zacks Consensus Estimate of a loss of $1.21. This compares to loss of $1.20 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -38.02%. A quarter ago, it was expected that this company would post a loss of $1.34 per share when it actually produced a loss of $1.22, delivering a surprise of 8.96%.Over the last four quarters, the company has surpassed con ...

Financial Performance - Clene reported a net loss of $39.4 million, or $5.67 per share, for the year ended December 31, 2024, compared to a net loss of $49.5 million, or $9.43 per share, for the same period in 2023[13]. - Total revenue for 2024 was $342,000, a decrease of 47.7% compared to $654,000 in 2023[20]. - Product revenue decreased to $237,000 in 2024 from $498,000 in 2023, representing a decline of 52.5%[20]. - Comprehensive loss for 2024 was $39,528,000, compared to $49,508,000 in 2023, indicating a reduction of 20.2%[20]. - Net loss for 2024 was $39,400,000, an improvement of 20.4% compared to a net loss of $49,504,000 in 2023[20]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $12.2 million as of December 31, 2024, down from $35.0 million as of December 31, 2023[9]. - Cash and cash equivalents decreased to $12,155,000 in 2024 from $28,821,000 in 2023, a decline of 57.8%[21]. - Total assets decreased to $27,337,000 in 2024 from $52,341,000 in 2023, a reduction of 47.9%[21]. - Total liabilities decreased slightly to $36,194,000 in 2024 from $38,951,000 in 2023[21]. - Additional paid-in capital increased to $273,194,000 in 2024 from $255,913,000 in 2023, reflecting a growth of 6.7%[21]. Research and Development - Research and development expenses were $20.1 million for the year ended December 31, 2024, compared to $26.7 million for the same period in 2023, reflecting a decrease primarily due to lower expenses related to ongoing clinical trials[10]. - Research and development expenses were $20,058,000 in 2024, down 24.5% from $26,655,000 in 2023[20]. - Clene is collecting and analyzing biomarker NfL data from its NIH-sponsored Early Access Protocol (EAP) for evaluation in the third quarter of 2025[5]. Clinical Trials and Regulatory Updates - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 in ALS[5]. - Clene intends to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, designed to investigate the effects of CNM-Au8 on improved survival and delayed time to ALS clinical worsening events[7]. - The FDA provided guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval for CNM-Au8 in ALS[6]. - Overall Survival Improvement of 4.1 months was observed in participants treated with CNM-Au8 compared to a control group in the HEALEY ALS Platform Trial[6]. General and Administrative Expenses - General and administrative expenses decreased to $13.3 million for the year ended December 31, 2024, from $14.4 million for the same period in 2023[11]. Debt and Financing - Clene secured a new $10.0 million debt facility at a lower interest rate to replace the remaining outstanding $7.85 million debt balance with Avenue Capital[5]. - The weighted average common shares used to compute basic and diluted net loss per share increased to 6,954,133 in 2024 from 5,246,941 in 2023[20].

Core Insights - Clene Inc. reported its full year 2024 financial results and highlighted its ongoing clinical programs for neurodegenerative diseases, particularly ALS and MS [1][2][3] Financial Performance - Clene's cash, cash equivalents, and marketable securities totaled $12.2 million as of December 31, 2024, down from $35.0 million as of December 31, 2023 [8] - The company reported a net loss of $39.4 million, or $5.67 per share, for the year ended December 31, 2024, compared to a net loss of $49.5 million, or $9.43 per share, for the same period in 2023 [12] - Research and development expenses were $20.1 million for 2024, a decrease from $26.7 million in 2023, primarily due to lower expenses related to ongoing clinical trials [9] Clinical Development - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 for ALS [4][5] - The company is set to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, which aims to evaluate the effects of CNM-Au8 on survival and clinical worsening events in ALS patients [6][17] - Clene is collecting and analyzing neurofilament light chain (NfL) biomarker data from its NIH-sponsored Early Access Protocol (EAP) to support its NDA submission [4][5] Regulatory Engagement - Clene received written guidance from the FDA regarding a potential accelerated approval pathway for CNM-Au8 in ALS [3] - The company plans to meet with the FDA in the second quarter of 2025 to align on its statistical analysis plan for the NfL biomarker data [2][5] Debt and Financing - Clene secured a new $10.0 million debt facility to replace its outstanding $7.85 million debt balance, with a fixed interest rate of 12% [7] - The new debt facility is partially convertible into shares of Clene's common stock at a fixed conversion price of $5.67, representing a 30% premium to the stock price at signing [7] Market Position - Clene is focused on revolutionizing the treatment of neurodegenerative diseases, including ALS and MS, through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][15]

Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine, Inc. announced significant survival benefits from their treatment CNM-Au8® for ALS patients based on new analyses from the HEALEY ALS Platform Trial [1][5] Group 1: Survival Analysis Results - The analysis compared survival rates between participants receiving CNM-Au8 30 mg and those in Regimen A, with a follow-up period of up to 48 months [2] - The CNM-Au8 30 mg group achieved a median survival of 951 days compared to 753 days in the Regimen A group, resulting in a gain of 198 days (6.5 months) [6] - A covariate-adjusted RMST improvement of 124 days (4.1 months) was observed, with statistical significance (p=0.045) [6] Group 2: Enhanced Benefits in Specific Patient Subsets - In participants with baseline serum neurofilament light (NfL) levels > 33 pg/mL, median survival improved from 589 days (Regimen A) to 951 days (CNM-Au8), representing an 11.9 month gain [6] - This group experienced a 44% reduction in mortality risk (Cox HR: 0.556, p=0.006) and an RMST improvement of 197 days (6.5 months) [6] - Among participants meeting the core RESTORE-ALS Trial criteria, median survival improved from 628 days (Regimen A) to 1079 days (CNM-Au8), an increase of 451 days (14.8 months) [6] Group 3: Future Clinical Trials and Strategic Direction - Clene plans to launch the Phase 3 RESTORE-ALS study in mid-2025, which will serve as a confirmatory trial for FDA approval [5][11] - The company aims to discuss these findings with the FDA as part of their commercialization strategy [5]

SALT LAKE CITY, March 06, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will participate in a fireside chat at the 37th Annual Roth Conference and host 1x1 investor meetings. Date: Mar ...

Longitudinal ALS patient data from APST Research will enable a more robust analysis of the effect of CNM-Au8 on NfL biomarkersAPST Research data includes thousands of people living with ALS including clinical, survival, and longitudinal NfL data Clene plans to analyze the APST ALS NfL biomarker and clinical dataset to compare NfL change from its ongoing NIH-sponsored EAP to address the FDA’s request for supportive evidence of CNM-Au8’s effect on NfL reduction observed in the HEALEY ALS Platform TrialClene p ...

Core Viewpoint - Clene Inc. has secured a new $10 million debt facility to replace the remaining $7.85 million of Avenue Capital debt, which will enhance its cash position and support the new drug application for CNM-Au8 for ALS through an accelerated regulatory pathway [1][4] Group 1: Debt Facility Details - The new debt facility is a secured, partially convertible Note with a principal amount of $10 million, a maturity of eighteen months, and a fixed interest rate of 12% [2] - The first twelve months of the Note will be interest-only, and 65% of the Note is convertible into shares of Clene's common stock at a fixed conversion price of $5.67, representing a 130% premium to Clene's closing stock price on the signing day [2] Group 2: Previous Loan Agreement - In May 2021, Clene entered into a Loan and Security Agreement with Avenue Venture Opportunities Fund, borrowing a total of $20 million, with repayment beginning in July 2024 [3] - As of December 2024, Clene has $7 million of principal outstanding under the previous agreement, along with a final payment fee of $0.85 million, totaling approximately $7.9 million including a prepayment penalty [3] Group 3: Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS and multiple sclerosis, through its investigational therapy CNM-Au8 [5] - CNM-Au8 aims to improve mitochondrial health and neuronal function, targeting mitochondrial function and reducing oxidative stress [5][6]